Our Transitions: Improving the Path to Menopause With Personal Digital Health Technologies

Sponsor
4YouandMe
Study ID
NCT07597915
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
FEMALE
Age
35 Years - 55 Years
Healthy Volunteers
Not accepted

Study Details

The goal of this observational study is to build knowledge about the path to menopause using subjective, self-reported and objectively measured information from multiple wearable study devices and a smartphone app. This study is being done in female individuals who are 35-55 years of age. The eventual aim of this work is two-fold; 1) to increase knowledge, awareness and education for individuals and clinicians about the lived experience of perimenopause and menopause through objectively measured data from digital study devices, and 2) to develop approaches to empower female individuals to manage this transition by learning what improves or worsens their symptoms.

Key Dates

First listed
May 20, 2026
Start date
May 1, 2026
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
1,250 participants (estimated)

Arms

  • Arm: Main Cohort
    Up to 250 participants aged 35-55 years old, residing in the US or Canada, who will be asked to complete surveys and active tasks in a study app, and use the Oura Ring Gen 4 and Fitbit Sense 2 daily. Participants will meet with research coordinators every 2 weeks to help support participation efforts and collect information on how the study and device use are going.
  • Arm: Hormone Sub-Cohort
    A sub-cohort of up to 75 participants will be invited to participate in a hormone sub-cohort. If the participant agrees to participate in this sub-cohort, they will be asked to complete daily at-home urine hormone samples provided to them for 3 consecutive menstrual cycles. The hormone sub-cohort procedure consists of peeing on a disposable urine test strip in the morning and then using a digital analyzer to produce the results, measuring Luteinizing Hormone (LH), Estrone-3-glucuronide (E3G), and Pregnanediol Glucuronide (PdG).
  • Arm: Bring Your Own Device (BYOD) Open Arm
    Once enrollment is complete in the main arm, and if the participant owns their own personal wearable device that includes an Oura ring, a Garmin smartwatch, Applewatch or Fitbit, they may be able to participate in the BYOD arm where they will participate by using the study app and providing the study investigators access to their wearable data. They will be asked permission for this wearable data sharing when they first download the study app during a number of opt-in screens. Up to 1000 participants may be enrolled in the BYOD arm.
  • Arm: Vire Clip Vasomotor Detection Sub-Cohort
    A subset of up to 70 participants will be invited to participate in a vasomotor detection cohort that will involve the use of a new wearable (Vire) clip capable of capturing core body temperature through heat flow, the dynamics of respiratory effort, and skin conductance measures at multiple layers into the skin. We want to learn whether these new wearable-derived signals could be used to detect when a vasomotor event will occur, like a hot flash, night sweat, cold sweat or feelings of sudden heating. If you meet certain eligibility criteria, you will be mailed the Vire clip and given instructions on how to set it up and sync with the study app. The Vire clip is a small clip that can be clipped onto the inside of your underwear.

Primary Outcome Measure

Feasibility: Retention [ Time Frame: From enrollment to the end of participation at 12 months ]

Central Contacts

Find similar trials

Nationwide
Menopause trialsWomen's health trialsFertility trials

Related Studies